Melatonin for Glycemic Control in Gestational Diabetes Mellitus

Phase 2Not Yet RecruitingNCT07369284

Obstetrics & Gynecology Hospital of Fudan University150 enrolled

Overview

The goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate whether melatonin supplementation improves glycemic control in pregnant women diagnosed with gestational diabetes mellitus (GDM). The main question it aims to answer is: Does melatonin supplementation help with glycemic control, especially in lowering fasting plasma glucose level? Researchers will compare melatonin to a placebo (a look-alike substance that contains no melatonin) to see if melatonin works to improve glycemic control. Participants will: 1. Take melatonin or a placebo every day after randomization until delivery 2. Visit the antenatal clinic once every 1 to 2 weeks for follow-ups

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

150

Conditions

Gestational Diabetes

Interventions

1. Melatonin tablets will be administered orally 0.5 to 1 hour before sleep and at least 2 hours after the last meal. 2. Participants will take 5 mg melatonin every night during the first week of intervention after randomization, followed by 10 mg melatonin every night from the second week until delivery.

PlaceboOTHER

1. Identical placebo tablets in terms of packaging, appearance, smell and taste will be administered orally 0.5 to 1 hour before sleep and at least 2 hours after the last meal. 2. Participants will take identical placebo tablets after randomization until delivery.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women aged 18 to 45 years * Singleton pregnancy * A diagnosis of GDM from a 75-g OGTT during 24 to 28 gestational weeks, according to the IADPSG criteria, with at least fasting plasma glucose (FPG) ≥ 5.1 mmol/L * Intending to receive obstetric care and deliver in the study center * Willing and able to provide written informed consent and follow the study procedure Exclusion Criteria: * Use of melatonin 1 month before pregnancy or/and during pregnancy * Night shift work or exposed to jetlag on a regular basis during pregnancy * Contraindications to melatonin use, including hypersensitive or allergic to melatonin * Use of antidepressive or antipsychotic medications which can interfere with melatonin metabolism and/or elimination, such as fluvoxamine, 5- or 8-methoxypsoralen, cimetidine, quinolones, and other CYP1A2 inhibitors; carbamazepine, rifampicin, and other CYP1A2 inducers; and zaleplon, zolpidem, zopiclone, and other non-benzodiazepine hypnotics * Pre-pregnancy diabetes, including patients diagnosed with diabetes before conception, fasting plasma glucose ≥ 7.0 mmol/L or HbA1c ≥ 6.5% in the first trimester, typical hyperglycemic symptoms or hyperglycemic crisis with random blood glucose ≥ 11.1 mmol/L * Other major diseases before gestation, e.g. hypertensive disorders, rheumatology or malignant diseases, infected with hepatitis B or hepatitis C, chronic diseases leading to impaired heart, liver, or renal function * Major fetal anomalies

Outcomes

Primary Outcomes

Change in fasting plasma glucose (FPG) from baseline to 36 to 38 gestational weeks

The primary outcome is defined as the change in FPG levels from baseline, measured at the time of OGTT performed between 24 and 28 gestational weeks, to follow-up assessment at 36 to 38 gestational weeks. For participants who deliver before 36 gestational weeks, the last available FPG measurement obtained will be used.

Time frame: Baseline (24 to 28 gestational weeks), and 36 to 38 gestational weeks

Secondary Outcomes

Change in glycated hemoglobin (HbA1c) from baseline to 36 to 38 gestational weeks

This outcome is defined as change in HbA1c levels from baseline, measured at the time of OGTT performed between 24 and 28 gestational weeks, to follow-up assessment at 36 to 38 gestational weeks.

Time frame: Baseline and 36 to 38 gestational weeks

Initiation of insulin therapy

This outcome is defined as the proportion of participants requiring initiation of insulin therapy.

Time frame: From baseline until delivery

Change in mean glucose levels assessed by continuous glucose monitoring (CGM)

This outcome is defined as the change in mean glucose levels measured by CGM at baseline and before delivery.

Time frame: Baseline and 36 to 38 gestational weeks

Gestational weight gain in late pregnancy

This outcome is defined as total gestational weight gain and the rate of weight gain from baseline to the last assessment prior to delivery.

Time frame: From baseline until delivery

Incidence of intervention-related adverse events

This outcome is defined as the proportion of participants reporting adverse events potentially related to study intervention, including but not limited to dizziness, hypersomnia, nausea, vomiting and hypoglycemia. Adverse events will be collected from participants' medication diaries and systematically assessed through participant self-report at each antenatal clinic visit.

Time frame: From initiation of the intervention until 6 weeks postpartum

Impact of melatonin on fetal growth

The antenatal use of melatonin on estimated fetal growth (grams) will be assessed using ultrasound biometry parameters performed every two to four weeks following trial recruitment until birth.

Time frame: From baseline until delivery

Percentage of time in range, time above range, and time below range measured by CGM

This outcome is defined as percentages of time in range, time above range, and time below range measured by CGM at baseline and before delivery.

Time frame: Baseline and 36 to 38 gestational weeks

Melatonin for Glycemic Control in Gestational Diabetes Mellitus

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts